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Can Heart Rate Variability analysis reduce analgesic requirements after laparoscopic cholecystectomy?

A randomised controlled pilot trial comparing the effectiveness of intraoperative Acute Nociception Index (ANI) monitoring on reducing moderate-severe pain in the Postanaesthesia Care Unit (PACU) in patients having elective cholecystectomy.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000953831
Enrollment
120
Registered
2012-09-05
Start date
2012-10-01
Completion date
2013-09-09
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study investigates whether using a new pain monitoring device, the ANI monitor, can better predict how much pain-killing medication patients having keyhole gallbladder surgery need. During gallbladder removal patients are asleep and unaware but still need pain-killing medication such as morphine or fentanyl to make sure they are not in severe pain when you wake up. Anaesthetist currently estimate how much pain-killing medication is needed based on factors including patient age, body weight, thepatients response to the surgery judged by blood pressure/heart rate monitoring and the anaesthetists clinical experience. Using these methods, patients sometimes wake up after surgery with severe pain because the prediction of dose for pain-killing medicine during surgery was incorrect. In this study, we will be testing a new pain monitor which may be able to more accurately predict a patients analgesia requirements during surgery. This monitor requires two gel electrodes to be placed on your chest, alongside the gel electrodes that are put on by the anaesthetist for standard heart monitoring. It records heart rate with great accuracy and using complex mathematical formulas, generates a number (the acute nociception index) which may better predict the pain levels while the patient is anaesthetized. This study compares the comfort of patients waking up after gallbladder surgery when the monitor is used compared with standard care.

Interventions

Dose of intraoperative intravenous analgesia administration (morphine or fentanyl) based on measurement of autonomic tone using the Acute Nociception Index (ANI) monitor. The ANI monitor is a modified ECG monitor that uses a software algorthim to measure variation in the ECG R-R interval to generate an index for the patients autonomic tone. Dose ranges MORPHINE 3-5mg (give 5mg if ANI < 30), max cumulative dose 40mg (age<50), 30mg (age<75) OR FENTANYL 30-50mcg (give 50mcg if ANI < 30), max cumula

Dose of intraoperative intravenous analgesia administration (morphine or fentanyl) based on measurement of autonomic tone using the Acute Nociception Index (ANI) monitor. The ANI monitor is a modified ECG monitor that uses a software algorthim to measure variation in the ECG R-R interval to generate an index for the patients autonomic tone. Dose ranges MORPHINE 3-5mg (give 5mg if ANI < 30), max cumulative dose 40mg (age<50), 30mg (age<75) OR FENTANYL 30-50mcg (give 50mcg if ANI < 30), max cumulative dose 400mcg (age<50), 300mcg (age<75) Review ANI after 5 minutes and repeat bolus as above if ANI score remains below 50. Repeat after every 5 minutes until ANI score >50 (maximum morphine dose permitted 40mg if age<50, 30 mg if age 50-75- or fentanyl equivalent)

Sponsors

Peninsula Health (Frankston Hospital)
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 74 Years
Healthy volunteers
No

Inclusion criteria

Elective laparoscopic cholecystectomy

Exclusion criteria

Inability to obtain informed consent from patient Cognitively impaired patients Emergency cholecystectomy Non-sinus rhythmn cardiac status Known impairment of the autonomic nervous system Pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 18, 2026